Side Effects

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Human insulin may cause hypoglycaemia (low blood sugar). See more information on hypoglycaemia below in the subsection “Common problems of diabetes”. Possible side effects Systemic allergy is very rare (affects less than 1 person in 10,000). The symptoms are as follows: • fall in blood pressure • rash over the whole body • difficulty in breathing • wheezing • fast heart beat • sweating If you think you are having this sort of insulin allergy with Humulin M3, tell your doctor at once. Local allergy is common (affects less than 1 person in 10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor. Skin changes at the injection site: If you inject insulin too often at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes. Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose. Common problems of diabetes A. Hypoglycaemia Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if you: • take too much Humulin M3 or other insulin; • miss or delay meals or change your diet; • exercise or work too hard just before or after a meal; • have an infection or illness (especially diarrhoea or vomiting); • have a change in your need for insulin; or • have trouble with your kidneys or liver which gets worse. Alcohol and some medicines can affect your blood sugar levels. The first symptoms of low blood sugar usually come on quickly and include the following: • tiredness • rapid heartbeat • nervousness or shakiness • feeling sick • headache • cold sweat Until you become confident in recognising your warning symptoms, avoid situations such as driving a car, in which you or others would be put at risk by hypoglycaemia. Do not use Humulin M3 if you think hypoglycaemia (low blood sugar) is starting. If your blood sugar is low, eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. B. Hyperglycaemia and diabetic ketoacidosis Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by: • not taking your Humulin M3 or other insulin; • taking less insulin than your doctor tells you to; • eating a lot more than your diet allows; or • fever, infection or emotional stress. Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following: • feeling sleepy • no appetite • flushed face • fruity smell on the breath • thirst • feeling or being sick Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately. If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) are not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death. Three simple steps to avoid hypoglycaemia or hyperglycaemia are: • Always keep spare syringes and a spare vial of Humulin M3. • Always carry something to show you are diabetic. • Always carry sugar with you. C. Illness If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your diabetes specialist nurse or doctor. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie, Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal, United Kingdom (Great Britain and Northern Ireland): Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.